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Brain and Central Nervous System TumorsPhase 1NCT00031928

Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors

A Phase 1 study testing mafosfamide in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors. Read more about this study

Who is it for?
Ages 3 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
mafosfamide
How many people
3,000 participants
Where
9 sitesUnited States
Study dates
Jan 2002to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of leukemia or lymphoma with meningeal involvement defined as cerebrospinal fluid cell count at least 5/mm^3 AND evidence of blast cells on cytospin preparation or by cytology OR
  • Diagnosis of other solid tumor with meningeal involvement defined as presence of tumor cells on cytospin preparation or cytology OR presence of measurable meningeal disease on CT or MRI scan
  • Meningeal malignancy must be progressive or refractory to conventional therapy
  • Meningeal malignancies secondary to an underlying solid tumor are allowed at initial diagnosis provided there is no conventional therapy
  • No concurrent bone marrow relapse in leukemia or lymphoma patients
  • No clinical evidence of obstructive hydrocephalus or compartmentalization of the cerebrospinal fluid flow as documented by a radioisotope indium In 111 or technetium Te 99-DTPA flow study
  • Patients demonstrating restored flow after focal radiotherapy are allowed

PATIENT CHARACTERISTICS:

Age:

  • Over 3

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • Not specified

Hepatic:

  • No clinically significant liver function abnormalities

Renal:

  • No clinically significant renal function abnormalities

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • No clinically significant metabolic parameter abnormalities (e.g., electrolytes, calcium, and phosphorus)
  • No significant systemic illness (e.g., infection)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Recovered from prior immunotherapy

Chemotherapy:

  • At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine (liposomal)) and recovered
  • Concurrent systemic chemotherapy to control systemic or bulk CNS disease allowed with the following exceptions:
  • No phase I agent
  • No agent that significantly penetrates the CNS (e.g., high-dose systemic methotrexate (more than 1 g/m^2), high-dose cytarabine (more than 2 g/m^2), IV mercaptopurine, fluorouracil, topotecan, or thiotepa)
  • No agent known to have serious unpredictable CNS side effects

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • At least 8 weeks since prior craniospinal irradiation
  • Local radiotherapy for symptomatic or bulky CNS disease must be given prior to induction therapy
  • No concurrent whole brain or craniospinal irradiation
  • Concurrent partial brain (e.g., base of brain) or limited-field spinal radiotherapy for asymptomatic bulky (radiographically visible) CNS disease allowed
  • Total CNS radiotherapy dose must not exceed accepted safe tissue tolerances

Surgery:

  • Not specified

Other:

  • At least 1 week since any prior CNS therapy
  • At least 7 days since prior intrathecal investigational agent
  • At least 14 days since prior systemic investigational agent
  • No other concurrent intrathecal or systemic investigational agent
  • No other concurrent intrathecal or systemic therapy to treat meningeal malignancy
  • No other concurrent intrathecal therapy or agent that significantly penetrates the blood-brain barrier
  • No concurrent agent known to have serious unpredictable CNS side effects

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites
  • Neurological Research Center, Inc.

    Bennington, Vermont, 05201

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Texas Children's Cancer Center

    Houston, Texas, 77030-2399

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-0700

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

Other trials in United States

About this study

Official title: Phase I Study of Intrathecal Mafosfamide

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors.

Read the detailed description

OBJECTIVES:

  • Determine the qualitative and quantitative toxicity of mafosfamide in patients with progressive or refractory meningeal malignancy.
  • Determine the maximum tolerated dose of this drug in these patients.
  • Determine the cerebrospinal fluid pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive intrathecal mafosfamide over 20 minutes twice weekly for 6 weeks (induction therapy). Patients then receive intrathecal mafosfamide once weekly for 4 weeks (consolidation therapy), twice a month for 4 months, and then monthly thereafter (maintenance therapy) in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of mafosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3000 patients will be accrued for this study.

Being tested
mafosfamide
Keywords
leptomeningeal metastases
Medical subject headings
Central Nervous System Neoplasms, Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mafosfamideDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00031928
Sponsor's protocol ID
CDR0000069240
Other IDs
NCI-90-C-0095K, BCM-H-3241
Status last verified
Nov 2003
First submitted
8 Mar 2002
Last updated
30 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mafosfamide in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.

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